Implementing Structured Content – Labeling and Medical Writing

This talk will discuss the different challenges within Labeling and Medical Writing as they have attempted to adopt Structured Content. We will discuss the planning and key considerations
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This talk will discuss the different challenges within Labeling and Medical Writing as they have attempted to adopt Structured Content. We will discuss the planning and key considerations Organizations conduct prior to implementing Structured Content, and some of the results we’ve seen to date. For labeling, we will trace the lineage from initial SPL requirements through today. We will discuss some of the readiness and implementation challenges groups faced as they try to keep pace with the demands of the Business and their desire for technical solutions. We will discuss techniques for adopting Structured Content within Labeling and Medical Writing, building toward a harmonized technology that is User focused and achievable.
The talk will draw on experiences in deploying Content Management within a Pharmaceutical Company for Labeling, as well as Market research and the recent trend in the potential of the Industry moving to Structured Content.
Key questions we’ll cover:
• How to get started with a SCM project for your Business?
• Key considerations for your Implementation
• What level of granularity in share Content?
• Methods for Change Management
• Methods for Shared Content
• Internal challenges and building a Business Case, e.g. Regulatory requirements and feature requirements
• Potential use of Structured Content beyond re-use, Authoring and Compliance

Now after looking back, I would like to focus on where I’ve seen the industry moving and methods people are taking to get there.

One way to begin a Project or Program is to develop a vision, a high-level Business Case that you can begin to socialize internally and get momentum for.

In talking with a number a growing companies, they have unique challenges when discussing RIM. As products are getting approved, and with further innovation ever changing, theses companies often are moving a pace that is difficult to manage. As the revenue is increasing, staff is increasing and the knowledge needs to be managed and transferred.In some instances, the smaller/mid-size companies are partnered with Larger companies for certain Products/Programs. These partnerships increase complexity, as the Department is now trying to manage their Internal records, Agency-drive records and also support their Partner company. The challenges for reporting, access and maintenance are ever-growing as the companies success story grows. Outsourcing is often utilized CRO’s, submission publishing and then the hand-over is challenging as they try to manage the interactions with Agencies and bridge the Gap.

SCM is appealing, but we need to consider how technically and procedurally it will fit into the overall architecture. Disruption is grounds for fear, uncertainty and doubt. We are proposing to move people out of their comfort zone, so let’s not turn their world upside down.

ROI is critical, and has been a roadblock in my experience to adoption of SCM. Companies have invested in Document Management, eCTD and other requirements. Executives are skeptical of spending more Capital.

Here are 3 useful methods for evaluating a solution, all of which will give you a chance to Pre-view a solution prior to purchasing and help prove a Business Case.

Once the regulatory review process is introduced, Labeling differs from other opportunities and simpler Use Caes for SCM.

Europe is a great example of the complexities that the Labeling Use case contains. The various presentations and strengths turns a 60 page document into an 800 page document.Audio: Product Information Management, or PIM, was developed to help ease the burden of translations into over 20 languages in the EU. This is a graphical representation of the Anatomy of Product Information in the EU – (1x) you can see the exponential number of documents and complexity in managing all that information for a single productGraphics Note:Darken the blue box. Programming Notes:At 1x highlight pack size over (not flag)

Statistical Analysis Plan is in Green, Protocol and the CSR

In my past life we trained

As you collect requirements, I want to take some time to review what I see as key roles to any successful project…

Oftentimes, these Projects need Sponsorship, e.g. a Senior member of the Department who sees and understands the goal of the Project.Key to Budget discussionsKey for Presenting the Project to Senior ManagementSounding board and potentially decision maker for a Project as it gets started and progresses toward implementation

The Business Lead in my view is the Pivotal role in a successful implemnetation –They are the Quarterback – they understand the Business, and know enough about the Solution to translate between IT and the Business UsersThey also work with the Champion – they are the conduit between the Users, IT and Senior Management.Build consensus, make priorities

Who ever the IT person is, you need one Depending on the project, this does not have to be a labor intensive effort. We will talk later about deployment approaches, what I would stress for IT, you need someone who understands the current Infrastructure at your company.They can also help manage competing projects and priorities and help keep your project on schedule20% of their time

In addition to Resource impacts, one often-overlooked aspect of a Project plan is the needs of the Users.Consider the whole picture when thinking about the Users of the Solution:What Policy are impacted, or do we need new ones?What kind of Training will be needed and when?Identify who will be responsible for the Updating, Accuracy and reporting of the Information in the system.

Shifting from the Process and Planning, I will discuss different Technology approaches that are prevalent.There is the classic internal implementation that we are used to, where we deploy IT solutions at our Data Centers, and our IT staff maintain them.More commonly, Pharma companies are looking for hosted solutions. Hosting is a great way to cut down your own IT needs, and have a vendor support the system.For example at Virtify– we work with Sidus as our hosting vendor. The benefits we’ve seen with Sidus is that they are vendor the FDA uses, which give us and our clients the assurance that there is a robust solution in place. Sidus has been a great partner of ours.

And finally, start with a High-value target – keep your eye on the Goals and the ROI you’ve developed and do not lose sight of the Users throughout your deployment.I will now hand it back to Satish.